- Galera Therapeutics Inc (NASDAQ:GRTX) has announced corrected results from its Phase 3 ROMAN trial of avasopasem for RT-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC).
- The corrected data showed that avasopasem achieved statistical significance on the primary endpoint of reduction in the incidence of SOM.
- Previously it announced that the trial did not achieve statistical significance on the primary endpoint.
- An error was identified in the statistical program upon further analysis, resulting in improved p-values.
- 16% relative reduction in the incidence of SOM in the avasopasem treatment group (54%) vs. placebo group (64%) (p=0.0451) (previously p=0.113) (primary endpoint)
- 56% relative reduction in the number of days of SOM in the avasopasem treatment group (8 days) vs. placebo group (18 days) (p=0.0022) (previously p=0.011) (secondary endpoint)
- 27% relative reduction in the severity of SOM in the avasopasem treatment group (24%) vs. placebo group (33%) (p=0.052) (previously p=0.167).
- The Company also announced topline results from its single-arm Phase 2a EUSOM trial of avasopasem in Europe.
- Avasopasem appeared to be generally well tolerated. In EUSOM, the incidence of SOM was 54.5%, and the median number of days of SOM was 9 days, in line with the ROMAN trial.
- Price Action: GRTX shares are up 116.4% at $2.99 during the market session on the last check Tuesday.
